510(k) · Cleared
Recalled · Class II · 2024Inflamma Dry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Pathogen Screening, Inc. · PFQ Mmp-9 Test System
Cleared on Nov 21, 2013 as substantially equivalent to K083184 (Ocusense, Inc., 2009) after a 141-day review. Its family tree reaches back 4 generations to 1994. It has been recalled 3 times.
- Decided
- Nov 21, 2013
- Review
- 141 days
- Class
- Class I
- Product code
- PFQ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940043 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940043 Bioscan Reagent StripsBioscan Instruments, Inc. · 1994
- 3 generations backK961375 Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996
- 2 generations backK971976 Diascreen Reagent StripsDia-Screen Corp. · 1997
- 1 generation backK083184 Tearlab Osmolarity SystemOcusense, Inc. · 2009
- This deviceK132066 Inflamma DryRapid Pathogen Screening, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940043 | Bioscan Reagent Strips | Bioscan Instruments, Inc. | 1994 | — |
| −3 | K961375 | Dia Screen 10 Way Reagent Strips | Genesis Labs, Inc. | 1996 | — |
| −2 | K971976 | Diascreen Reagent Strips | Dia-Screen Corp. | 1997 | — |
| −1 | K083184 | Tearlab Osmolarity System | Ocusense, Inc. | 2009 | — |
| 0 (this device) | K132066 | Inflamma Dry | Rapid Pathogen Screening, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PFQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083184 | Tearlab Osmolarity SystemSummary page 1…ss 1,reserved Panel: . Chemistry (75) 4. Predicate Device For InflammaDry: OcuSense, Inc., TearL-ab m Osmolarity System (K083184) For InflammaDry External Controls: Predicate name: .TearL-ab Control Solutions (K(083184) 5.… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2024 | Class II | Z-1637-2024 | Process design | There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/… |
| Mar 5, 2024 | Class II | Z-1636-2024 | Process design | There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/… |
| Jun 22, 2017 | Class II | Z-2803-2017 | Process design | In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All PFQ devicesPFQ Mmp-9 Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PFQ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PFQ
Too few PFQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PFQ
No recall names PFQ since 2007.
Adverse event reports per year · PFQ
2in 2018
MAUDE reports naming product code PFQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
InflammaDry External Controls are QC materials used for verifying the performance of the InflammaDry test reagents and assay. These controls can also be used to assist in operator training and troubleshoot invalid results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132066: Inflamma Dry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132066
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026